Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Herlev Hospital
Sponsor:
Collaborator:
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01543464
First received: February 8, 2012
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.


Condition Intervention Phase
Malignant Melanoma
Drug: Chemotherapy: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Clinical benefit rate (CBR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine+adjuvants+temozolomide treatment
Experimental arm
Drug: Chemotherapy: Temozolomide
Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week

Detailed Description:

Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological verified malignant melanoma
  2. Metastatic disease (brain metastasis allowed if asymptomatic)
  3. Evaluable disease recording to RECIST v. 1.1
  4. Age > 18 years
  5. Performance status, PS=0, PS=1 or PS=2
  6. Life expectancy > 3 months
  7. Adequate bone marrow function
  8. Leucocyte count > 2,5 * 109/L
  9. Granulocyte count > 1,5 * 109/L
  10. Thrombocyte count > 100 * 109/l
  11. Creatinine < 2,5 * UNL 130 micromol/L
  12. Adequate liver function
  13. ASAT < 100 U/L
  14. Bilirubin < 300 U/L
  15. S-hCG negative (fertile women)
  16. Written informed consent
  17. Inclusion at least 4 weeks after major abdominal surgery
  18. If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion

Exclusion Criteria:

  1. Treatment with immune suppressors (ie. prednisone) not allowed
  2. Other malignancies 3 years prior to inclusion except benign skin lesions
  3. Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
  4. Acute/Chronic infection with HIV, hepatitis or tuberculosis
  5. Known severe allergic reactions
  6. Former anaphylactic reactions
  7. Active autoimmune diseases
  8. Pregnant or nourishing women
  9. Psychiatric disease resulting in non-compliance
  10. Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
  11. Simultaneously treatment with other experimental drugs

Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543464

Contacts
Contact: Trine Zeeberg Iversen, MD 38 68 91 83 ext + 45 trine.zeeberg.iversen@regionh.dk
Contact: Inge Marie Svane, MD, PhD 38 68 2131 ext + 45 inge.marie.svane@regionh.dk

Locations
Denmark
Trine Zeeberg Iversen Recruiting
Brønshøj, Copenhagen, Denmark, 2700
Contact: Inge Marie Svane, MD, PhD    38 68 21 31 ext + 45    imsv@regionh.dk   
Sponsors and Collaborators
Inge Marie Svane
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer ImmuneTherapy
Study Director: Inge Marie Svane, MD, PhD, Prof. Center for Cancer ImmunoTherapy
  More Information

No publications provided

Responsible Party: Inge Marie Svane, MD, PhD & Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01543464     History of Changes
Other Study ID Numbers: MM1120
Study First Received: February 8, 2012
Last Updated: January 29, 2014
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Herlev Hospital:
Indeolamine 2,3 dioxygenase
Survivin
Montanide
Imiquimod
GMCSF

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Imiquimod
Temozolomide
Dacarbazine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014